JP2020108812A - Sutureless valve prothesis delivery device and methods of use thereof - Google Patents

Abstract

To provide a sutureless valve prothesis delivery device useful in minimally invasive procedures.SOLUTION: A valve prothesis delivery device 100 includes a first sheath 110 for encasing a first component of the prosthetic valve. The first component has one of a valve clasper 140 and an expandable support frame 170, and includes a second sheath 120 for encasing a second component of the prosthetic valve. The second component has the other one of the valve clasper and the expandable support frame, and includes a control unit 260 operably coupled with the first sheath and the second sheath. The first sheath is distal of the second sheath and the second sheath is distal of the control unit, along a lengthwise axis. The first sheath or the second sheath has a bent configuration in which the first sheath or the second sheath is bent at an angle of at least about 5 degrees. The first sheath or the second sheath keeps the bent configuration if an external force is absent during delivery of the prosthetic valve and the recovering of the delivery device.SELECTED DRAWING: Figure 6

Description

CROSS REFERENCE TO RELATED APPLICATIONS This application claims benefit under 35 USC 119(e) of US patent application, Ser. No. 61/784,973, filed Mar. 14, 2013, referenced in its entirety. Incorporated herein by reference.

The subject matter described herein relates to medical devices and methods for implantation of sutureless prosthetic valve structures using minimally invasive procedures.

Prosthetic heart valves are used to replace damaged or diseased heart valves. In vertebrates, the heart is a muscular organ with four pump chambers, the left atrium, the right atrium, the left ventricle, and the right ventricle, each with its own one-way valve. Natural heart valves are identified as aortic, mitral (or bicuspid), tricuspid and pulmonary valves. Repair or replacement of the aortic or mitral valve is more common because the valve resides on the left side of the heart where pressure is greatest, but prosthetic heart valves do not include any of these naturally occurring valves. Can be used to replace.

Conventional heart valve replacement surgery involves accessing the heart within the patient's thoracic cavity through a longitudinal incision in the chest. For example, a midline sternotomy requires cutting the sternum and expanding the opposite halves of the rib cage to allow access to the internal chest cavity and heart. The patient is placed in cardiopulmonary bypass, which involves stopping the heart to allow access to the internal chambers. Such open heart surgery is particularly invasive and requires a long and difficult recovery period.

Minimally invasive surgical procedures are evolving, where a prosthetic valve can be introduced into a patient using, for example, a catheter introduced through a small incision that provides access to the femoral artery or directly to the heart. These transplantation techniques have shown promising results in providing treatment options for patients who are less suited to open surgery candidates. Nevertheless, challenges remain in catheter-based delivery such as artificial valves. Advancement of the tubular delivery device through the blood vessel stresses the vessel wall and risks damaging the vessel wall. For example, retrograde delivery of a valve through the femoral artery is associated with aortofemoral artery injury/rupture and is associated with a potential risk of stroke as delivery crosses the aortic arch. Therefore, it is also advantageous to design a prosthetic valve delivery system that minimizes damage along the delivery path of the device while also minimizing the invasive nature of the implantation procedure.

In one embodiment described herein, a prosthetic heart valve delivery device allows for implantation of an aortic prosthetic valve to repair a defective aortic valve. This device introduces an artificial valve into the left ventricle of the heart via an introducer (transapical). In other embodiments disclosed herein, a prosthetic valve delivery device is designed to utilize the relatively large diameter of arteries and veins that lead directly to the heart. Since the device is designed for use by the surgeon, for example, to percutaneously access these arteries and veins, the introduction of a delivery device will reduce the larger diameter of the blood vessel. It is performed relatively close to the heart for access.

The above examples of related art and related limitations are intended to be illustrative and not exclusive. Other limitations of the related art will be apparent to those of ordinary skill in the art having reference to the specification and consideration of the drawings.

The aspects and embodiments described and described below are for purposes of illustration and description only, and are not intended to limit the scope of the invention.

In one aspect, an implantation technique comprising a prosthetic valve and a delivery device is provided. The prosthetic valve comprises a valve grasper and a support frame that is radially expandable between a compact state and an expanded state, the support frame having an outer surface and having a central opening about an axis along the inflow and outflow directions. Stipulate. In one embodiment, the support frame and valve grasper are movably coupled. The delivery device comprises at least one track wire consisting of a control unit, a proximal end attached to the control unit and a distal end reversibly coupled to the valve grasper, in its compact state at least the support frame of the artificial valve. A first sheath that houses a portion and a second sheath that houses at least a portion of the valve grasper are provided. In one embodiment, the delivery device is useful for apical delivery of aortic valve prostheses.

In one embodiment, the delivery device houses a prosthetic valve.

In one embodiment, the first sheath is distal to the second sheath and the second sheath is distal to the control unit along the longitudinal axis. In other embodiments, the delivery device comprises a central lumen along the longitudinal axis of the delivery device.

In one embodiment, the valve grasper is moveable along an axis between an outer surface of the support frame and a nesting position and an engagement position.

In one embodiment, the valve grasper is comprised of two, three or four leg members and two, three or four U-shaped members. In another embodiment, each U-shaped member comprises a straight portion and a curved portion. In yet another embodiment, each of the leg members has first and second ends.
In one embodiment, the first end of the leg member is the distal end of the leg member and the second end of the leg member is the proximal end of the leg member. In yet another embodiment, each proximal end of the leg members has a hole.

In one embodiment, the valve grasper comprises a shape memory material. In other embodiments, the valve grasper is manufactured as a single piece.

In one embodiment, the support frame has a length L and each of the leg members has a length of at least L. In other embodiments, the support frame has a length L and each of the leg members is less than L in length. In yet another embodiment, the support frame has a length L and each of the leg members has a length of approximately L.

In another embodiment, the support frame has a radius r in its expanded state, and when the support frame is in its expanded state, at least one valve grasper is dimensioned to be nested concentrically with the support frame. Is.

In one embodiment, the support frame is composed of shape memory material. In another embodiment, the support frame is at least partially covered by the cover. In a particular embodiment, the cover is cloth. In another embodiment, the support frame is balloon expandable.

In one embodiment, the support frame comprises a plurality of flexible leaflets attached to the support frame to provide a one-way valve at the orifice when the support frame is in its expanded state. In another embodiment, the plurality of flexible leaflets is constructed of biomaterial. In certain embodiments, the biomaterial is porcine or bovine.

In one embodiment, the delivery device further comprises a valve delivery body. In other embodiments, the valve carrier comprises a distal disc portion, a central stem portion and a proximal disc portion. In other embodiments, the valve carrier is fully contained within the first sheath. In one embodiment, the valve carrier includes a balloon that can be inflated to perform radial expansion of the support frame.

In one embodiment, the support frame is fully contained by the first sheath. In another embodiment, the support frame fully contained by the first sheath is located between the distal disc portion and the proximal disc portion of the valve carrier.

In one embodiment, the valve grasper is at least partially contained by the second sheath. In other embodiments, the U-shaped member is partially or fully contained by the second sheath. In yet another embodiment, the distal end of the valve grasper is fully contained within the first sheath.

In one embodiment, the first or second sheath is constructed of a bendable material and the sheath is bendable in a bent configuration such that the bend angle is between about 5 degrees and 60 degrees. 10 degree to 50 degree, 20 degree to 40 degree, 30 degree to 50 degree, 10 degree to 40 degree, 10 degree to 30 degree, 5 degree to 20 degree, 10 degree to 20 degree, 15 degree to 30 degree, 40 degree It is in the range of degrees to 60 degrees, 50 degrees to 60 degrees, or 30 degrees to 60 degrees. In other embodiments, the first or second sheath maintains a bent shape during delivery of the prosthetic valve and removal of the delivery device.

In one embodiment, the first or second sheath comprises a metal support structure and a protective layer. In other embodiments, the metal support structure is tubular in shape. In yet another embodiment, the metal support structure comprises a metal wire mesh. In yet another embodiment, the metal support structure is made of one or more thin walls, flat wires, metal spiral coils. In one embodiment, the first or second sheath is composed of both a metal and a polymer that are manufactured together to form a long tube that can be bent into a bent shape, which can be part or all of the delivery. The curved shape can be maintained during the procedure.

In one embodiment, the walls of the first or second sheath are 0.04 mm to 1.0 mm, 0.05 mm to 0.7 mm, 0.05 mm to 0.1 mm, 0.05 mm to 0.3 mm or 0.04 mm. To 0.6 mm.

In one embodiment, the first or second sheath comprises a polymeric material. In still other embodiments, the polymeric material is Pebax, Teflon, or a similar polymer. In other embodiments, the polymer is a polyether-based polyamide. In still other embodiments, the polymeric material is Pebax, Teflon, or other similar polymer.

In one embodiment, the polymeric material of the first or second sheath is a protective cover over the metal support structure. In other embodiments, the protective cover is on the outer surface of the tubular metal support structure. In yet another embodiment, the protective cover is on the luminal surface of the tubular metal support structure.

In one embodiment, the first or second sheath comprises a metal support structure embedded in or impregnated with a polymeric material.

In one embodiment, the number of track wires is equal to the number of leg members. In yet another embodiment, the distal end of each track wire is threaded through a hole in the proximal end of the leg member. In yet another embodiment, the proximal end of each grasper connector cable is in operative contact with the control unit.

In one aspect, a method for delivering a sutureless prosthetic valve is provided, wherein the delivery device comprises a first sheath, a second sheath, and a control unit for delivering a sutureless prosthetic valve as described above. including.

In one embodiment, the method includes introducing a delivery device into the left ventricle of the subject's heart via an introducer.

In one embodiment, the method further comprises advancing the distal portion of the delivery device in the direction of blood flow through the left ventricle until the first sheath is positioned distal to the native aortic valve.

In one embodiment, the method further comprises moving the second sheath proximally to expose the valve grasper. In this embodiment, the first sheath having the contained support frame, the valve grasper and the control unit can be held stationary. In other embodiments, the U-shaped member of the valve grasper extends radially after the U-shaped member is exposed.

In one embodiment, the method further moves the delivery device proximally until the U-shaped member of the valve grasper contacts the natural valve sinus between the native leaflet and the vessel wall. Including that. In this embodiment, the method further includes moving the first sheath with the contained support frame proximally to align the support frame with the valve grasper. In one embodiment, the proximal end of the support frame is generally aligned with the proximal end of the U-shaped member.

In another embodiment, after the valve grasper is exposed, the first sheath with the contained support frame is moved proximally while the valve grasper is aligned with the support frame. Is held stationary along the longitudinal axis up to. In one embodiment, the first sheath is moved proximally until the proximal end of the support frame is generally aligned with the proximal end of the U-shaped member. In one embodiment, the method further comprises moving the delivery device proximally until the U-shaped member of the valve grasper contacts the natural valve sinus between the native leaflet and the vessel wall. Including that.

In one embodiment, the method further comprises advancing the first sheath distally while holding the support frame stationary along the longitudinal axis.

In one embodiment, the method further comprises disconnecting the distal end of each track wire from the respective proximal ends of the leg members of the valve grasper.

In one embodiment, the method further comprises moving the second sheath distally until the distal end of the distal sheath is substantially adjacent and/or in contact with the proximal end of the first sheath. Including.

In one embodiment, the method further comprises moving the delivery device proximally to remove the delivery device from the subject.

In one aspect, a sutureless prosthetic valve delivery device for antegrade delivery of a sutureless valve is provided.

In one aspect, an implant device is provided that includes a delivery device and a prosthetic valve. In one embodiment, the delivery device comprises a first sheath, a second sheath and a control unit. In other embodiments, the first sheath is distal to the second sheath and the second sheath is distal to the control unit. In other embodiments, the delivery device comprises a central lumen along the longitudinal axis of the delivery device.

The prosthetic valve includes a valve grasper and a support frame that is radially expandable between a compact state and an expanded state, the support frame having an outer surface and a central orifice about an axis along the inflow and outflow directions. Stipulate. The valve grasper has a circular shaft with a central lumen and comprises two, three or four leg members and two, three or four U-shaped members. In one embodiment, the valve grasper and the support frame are movably coupled.

In one embodiment, the top member is between two U-shaped members. In another embodiment, the top member is disposed between the one U-shaped member and the one leg member and is coupled to the one U-shaped member 1 and the leg member. In another embodiment, the grasper unit is made up of three U-shaped members and three leg members. In another embodiment, the grasper unit is composed of shape memory material.

In one embodiment, the prosthetic valve includes at least one suture loop in contact with the support frame and the valve grasper. In another embodiment, each of the at least one suture loop is movably attached to the valve grasper. In yet another embodiment, each of the at least one suture loop is attached to one of the leg members of the valve grasper. In other embodiments, the suture loop can slide along the leg member along the longitudinal axis of the leg member. In yet another embodiment, the suture loop is fixed to the support frame and movably attached to the leg member.

In one embodiment, the prosthetic valve includes a plurality of flexible leaflets attached to the support frame to provide a one-way valve to the orifice when the support frame is in the expanded state, and a valve grasper. Are axially movable between a position nested with the outer surface of the support frame and an engaged position. In one embodiment, the support frame is composed of shape memory material.

In one embodiment, the support frame has a length L and each straight portion of the U-shaped member has at least a length L. In another embodiment, the support frame has a length L and each straight portion of the U-shaped member has a length less than L. In yet another embodiment, the support frame has a length L and each straight portion of the U-shaped member has a length of approximately L. In yet another embodiment, the support frame is at least partially covered by a cover. In a particular embodiment, the cover is cloth. In one embodiment, the support frame is not self-expanding and can be expanded using, for example, a balloon catheter as is known in the art.

In one embodiment, the delivery device includes a control unit, a first sheath that houses the distal portion of the valve grasper leg member, and, in its compact state, a second sheath that houses the support frame of the prosthetic valve, and at least The U-shaped member of the valve grasper in a compact state is provided.

In one embodiment, the delivery device comprises a locking member that is at least partially housed by the first sheath. In other embodiments, at least a portion of each distal end of the leg members is disposed between the locking member and the inner wall of the first sheath. In yet another embodiment, the locking member is disc shaped. In another embodiment, the locking member functions to hold the grasper stationary while the distal portion of the grasper is located between the outer surface of the locking member and the inner surface of the first sheath, while The two sheaths are moved proximally along the longitudinal axis.

In one embodiment, the prosthetic valve is an aortic prosthetic valve, a pulmonary prosthetic valve, a mitral prosthetic valve, or a tricuspid prosthetic valve.

In one embodiment, the second sheath is constructed of a pliable material. In other embodiments, the second sheath comprises a braid of metal wires, a wire mesh and/or a metal support structure of a wire coil. In other embodiments, the second sheath can be sufficiently bent to conform to the curvature of the vessel through which the delivery device is advanced. The wire support structure of the second sheath is constructed so that the second sheath can be bent at a particular angle before the delivery device is introduced into the patient. Once bent, the second sheath maintains the bend angle throughout delivery of the prosthetic valve and retrieval of the delivery device. The bend angle can be matched or adapted to the delivery of the prosthetic valve to the natural annulus so that delivery does not damage the natural tissue near the point of valve replacement, or if the second sheath The damage can be reduced as compared to the damage that occurs when is straight or has a bending angle of about 5 degrees or less or about 3 degrees or less.

The second sheath can include a polymeric material or other suitable material that can cover the metal support structure described above. Alternatively, the metal support structure may be embedded in or impregnated with the polymeric material. Examples of some suitable polymers include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, such as DELRIN (available from DuPont). )), polyether block ester, polyurethane (eg polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether-ester (eg ARNITEL®, available from DSM Engineering Plastics). ), ether- or ester-based copolymers (eg, butylene/poly(alkylene ether) phthalates and/or other polyester elastomers such as HYTREL® available from DuPont), polyamides (eg available from Bayer) DURETHAN® or CRISTAMID® available from Elf Atchem), elastic polyamides, block polyamide/ethers, polyether block amides (PEBA, available under the trade name PEBAX®), ethylene acetic acid Vinyl Copolymer (EVA), Silicone, Polyethylene (PE), Marlex High Density Polyethylene, Marlex Low Density Polyethylene, Linear Low Density Polyethylene (eg REXELL®), Polyester, Polybutylene Terephthalate (PBT) ), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyether ether ketone (PEEK), polyimide (PI), polyether imide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO) ), polyparaphenylene terephthalamide (eg KEVLAR®), polysulfone, nylon, nylon-12 (eg GRILAMID® available from EMS American Glylon), perfluoro(propyl vinyl ether) (PFA). ), ethylene vinyl alcohol, polyolefin, polystyrene, epoxy, polyvinylidene chloride (PVDC), poly(styrene-£-isobutylene-£-styrene) (e.g., SIBS and/or SIBS50A), polycarbonate, ionomer, biocompatible polymer, Other suitable materials, or mixtures thereof, Including these combinations, their copolymers, polymer/metal composites, and the like. In some embodiments, the sheath can be blended with a liquid crystal polymer (LCP). For example, the mixture can contain up to about 6% LCP.

In other embodiments, the first sheath may be composed of a metal support structure and/or polymer as described for the second sheath.

In another aspect, a method of delivering a sutureless prosthetic valve using a retrograde approach is provided, the method comprising use of an implant device comprising a delivery device as described above, the implant device comprising a control unit, a delivery device. The device and the prosthetic valve are included, and the support frame and valve grasper are housed in the second sheath. In the present device, useful for percutaneous delivery of a prosthetic valve through a blood vessel leading to the heart, the vesicles are accessed via surgical means. For example, the device can provide a prosthetic valve to replace the natural lung or atrial valve by retrograde delivery of the prosthesis.

In one embodiment, the method includes inserting the distal end of the delivery device into a blood vessel of a patient by inserting the device into an incision made in the blood vessel. The device then advances in the opposite direction of blood flow to the annulus. In one embodiment, the delivery device is advanced until the first sheath is generally positioned within the annulus to be repaired. The second sheath is then moved proximally until the U-shaped member of the valve grasper is allowed to expand radially from the longitudinal axis of the delivery device. In one embodiment, the first sheath and valve grasper are held stationary when the second sheath is moved proximally.

In one embodiment, the method then comprises moving the second sheath distally while the first sheath and valve grasper are held stationary along the longitudinal axis.

In one embodiment, the method then includes moving the second sheath distally until the support frame is aligned with the valve grasper.

In one embodiment, the method then moves the delivery device distally until the U-shaped member of the valve grasper contacts the native valve sinus between the native leaflet and the vessel wall. Including that.

In one embodiment, the method then includes the second sheath holding the support frame stationary along the longitudinal axis until the support frame is radially expanded and contacts the natural leaflets. In a proximal direction, wherein the U-shaped member of the valve grasper is located between the vessel wall and the native leaflet, the native leaflet of the U-shaped member and the outer surface of the support frame. Located in between.

In one embodiment, the method then includes moving the delivery device in a proximal direction. In other embodiments, the delivery device is removed from the patient.

In one embodiment, the method includes imaging the position of the native valve to be replaced prior to inserting the delivery device into the patient. In other embodiments, the second sheath of the delivery device is bent to form a bent configuration having an angle compatible with that of the native valve structure. In yet another embodiment, the second sheath of the delivery device is bent to form a bent configuration or structure prior to or during delivery of the prosthetic valve.

Further embodiments of the apparatus and method of the present invention will be apparent from the following description, drawings, examples, and claims. As will be understood from the foregoing and following description, all features described in this specification, and each combination of two or more such features, are to the extent that the features contained in such combinations are mutually exclusive. Within the scope of the present disclosure. Moreover, any feature or combination of features may be specifically excluded from any embodiment of the present invention. Additional features and advantages of the invention will be set forth in the description and claims that follow, and will be particularly apparent when considered in conjunction with the examples and drawings.

1 and 2 show an embodiment of a valve grasper operably coupled to a support frame.

3A and 3B show embodiments of a valve carrier without and with a support frame, respectively.

FIG. 3C illustrates an embodiment of a track wire reversibly coupled to a leg member of a valve grasper.

4-7 illustrate an embodiment of a delivery device for antegrade delivery of a sutureless prosthetic valve.

8-10 illustrate an embodiment of a delivery device for retrograde delivery of a sutureless prosthetic valve.

11-12 illustrate an embodiment of a flexible sheath for delivering a sutureless prosthetic valve.

FIG. 13 illustrates an embodiment of a sutureless artificial valve implanting device including a spring mechanism.

Detailed Description of the Invention

Various aspects are described in more detail below. However, such aspects may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope to those skilled in the art.
1. Valve grasper and support frame

The implantation device described herein comprises a delivery device configured to deliver a prosthetic valve to a defective heart valve of a patient. The prosthetic valve includes a valve grasper operably coupled to a radially expandable support frame that includes a prosthetic leaflet. The valve graspers described herein are movable with respect to and along the longitudinal axis of the support frame. If the valve grasper is off-set from the support frame, for example, the U-shaped member of the valve grasper is at a proximal or distal position of the support frame and/or almost fully This position is called the engagement position if it does not overlap. In this position, the U-shaped member of the valve grasper may extend radially from the leg member and the longitudinal axis of the support frame in its compact state. The U-shaped member can also move proximally or distally along the longitudinal axis when the support frame is held stationary in a compact state. When the valve grasper is in the nested position, the apex of the grasper is approximately adjacent to the end of the support frame aligned with the floor of the native valve sinus. Alternatively, the valve grasper is in its nested position when at least a portion of the U-shaped member is in contact with or adjacent to the natural sinus floor or commissure of the natural leaflets of the valve. Sutureless valves are further described, for example, in US Pat. No. 8,366,768, the entire contents of which are incorporated herein by reference.

The valve grasper has a circular shaft and is composed of two, three or four U-shaped members separated by leg members. In some embodiments, each leg member has a lumen along the longitudinal axis of the leg member, the lumen being movable along the longitudinal axis of the leg member, eg, while still coupled to the leg member. Allows attachment of possible suture loops or other means. Thus, the suture loop can slide along the lumen. In the described prosthetic valve, the suture is also attached to the support frame. The attachment to the support frame may be immobile or it may have limited mobility with respect to the support frame. In this configuration, where the suture loop is attached to both the support frame and the lumen of the leg member of the valve grasper, the support frame and the valve grasper can be movably attached.

The valve grasper is movably coupled to the support frame (alternatively "movably mounted") such that the valve grasper is concentric with the support frame from a proximal or distal position of the support frame. Can be moved to a position. During delivery of the artificial valve, it is advantageous to place the valve grasper in series with the support frame. This allows the user, for example, to minimize the radius of the device that has to be advanced through arteries and veins. Because the distance that the valve grasper can be displaced in series from the support frame can vary widely, the valve grasper may be adjacent to the support frame or away from the support frame in inches or feet during the transfer procedure. May be. In some embodiments, no portion of the valve grasper is physically secured to the support frame, such as by welding or otherwise gluing. Importantly, the portion of the valve grasper can move radially from the support frame. In any case, the valve grasper is movably coupled to the support frame. Those skilled in the art will appreciate that the means for movably connecting the support frame and the grasper are not limited to the suture loop shown in FIGS.

An example of a valve grasper movably attached to a support frame is shown in FIGS.
A valve grasper movably attached to the support frame 5 includes a valve grasper 10, an expandable support frame 15 and a suture loop 60. The valve grasper 10 comprises three leg members 30, each having a lumen 50 in which a suture loop 60 is slidable along its longitudinal axis. FIG. 1 represents the “engagement position” described herein. FIG. 2 is as if the valve grasper 10 and support frame 15 were properly positioned within the natural annulus (“nested position” as described herein) prior to placement of the support frame 15. , An embodiment in which the support frame 15 is aligned with the valve grasper 10.

Prior to delivery of the prosthetic valve to the defective natural annulus, the valve grasper and support frame are positioned adjacent to each other along the longitudinal axis with little or no overlap between each other ( For example, Figure 1). Both are also compact within the first and/or second cylindrical sheath or tube. During implantation of the prosthetic valve, the support frame can be concentric with and within the valve grasper (see, eg, FIG. 2). After placement of the support frame, each natural leaflet is placed between the leg member and the expanded support frame. The construction of the support frame in combination with the radial force secures the prosthetic valve within the natural annulus.

The support frame has an outer or outer surface and defines a central orifice about an axis (longitudinal axis). The longitudinal axis corresponds to the inflow/outflow axis. In some embodiments, the prosthetic valve further comprises a plurality of prosthetic valve leaflets attached to the inner surface of the support frame. The leaflets have a surface that defines an opening that can reversibly seal the flow of liquid in one direction through the prosthetic valve. The prosthetic valve can include three leaflets for a three-leaflet configuration. As will be appreciated, single-leaflet, double-leaflet, and/or multi-leaflet configurations are also possible. For example, the leaflets can be coupled to the valve frame to bridge and control the flow of fluid through the lumen of the prosthetic valve. Leaflets include synthetic materials, engineered biological tissue, biovalve leaflet tissue, pericardial tissue, cross-linked pericardial tissue, or combinations thereof. In other embodiments, the pericardial tissue is selected from the group consisting of, but not limited to, bovine, equine, porcine, ovine, human tissue, or a combination thereof.

The support frame can be self-expanding or balloon expandable. In some embodiments, the self-expanding support frame may be composed of a shape memory metal that is capable of changing shape at a specified temperature or temperature range. Alternatively, the self-expanding frame can include one with a spring bias. The material from which the support frame is made not only allows the support frame to automatically expand to its functional size and shape when deployed, but it also carries it through the patient's vasculature. It is possible to be compressed into a smaller shape in the radial direction. Examples of suitable materials for self-expanding components (eg, support frames, valve graspers, locking members) as described herein include medical grade stainless steel, titanium, tantalum, platinum alloys, niobium alloys. , Cobalt alloys, alginates, or combinations thereof, but are not limited thereto. Examples of shape memory materials include shape memory plastics, polymers, and thermoplastic materials that are inert in the body. A shape memory alloy with superelastic properties, commonly made from one having a certain ratio of nickel to titanium, commonly known as Nitinol, is a preferred material. In alternative embodiments, the support frame is not self-expanding and can be expanded, for example using a balloon catheter, as is well known in the art.

Prior to placement of the support frame, the support frame may be held stationary within the first sheath with a valve carrier. The valve carrier is shown in Figures 3A (without support frame) and 3B (with support frame). The proximal end 274 and the distal end 275 of the valve carrier 270 have a circumference that allows each end to be pressed radially against the wall of the first sheath. The support frame 280 shown in FIG. 3B is located between the proximal end 274 and the distal end 275. The central stem runs longitudinally between the proximal and distal ends of the valve carrier. In one embodiment, the central stem may include a balloon that may be inflated after moving the support frame from the first sheath to effectuate the placement of the support frame. Such an embodiment may be used where the support frame is not shape memory metal.
II. Prosthetic valve delivery device for delivering aortic prosthetic valve

The present disclosure describes a delivery device capable of, for example, transapical delivery of a sutureless prosthetic valve through the apex of the left ventricle of a mammalian heart. Such methods include using a trocar to provide a delivery passageway through the patient's chest. However, the devices described below are not limited to aortic valve repair.

An “antegrade” delivery device refers to a device that is delivered to a patient through a blood vessel (vein or artery) or blood chamber (eg, ventricle or atrium) in the direction of blood flow through the blood vessel or blood chamber.

A "retrograde" delivery device refers to a device that is delivered to a patient through a blood vessel (vein or artery) in the opposite direction of blood flow through the blood vessel.

An implant device with a delivery valve and an artificial valve is described in Figures 4-7 and below.

This device and its variants can be used for antegrade delivery of artificial valves. In other words, the device and method are useful for the delivery and implantation of prosthetic valves, where the distal end (nose cone) of the device is advanced towards the natural annulus in the direction of blood flow. This delivery device can be used for repair of the aorta, mitral valve, pulmonary valve or tricuspid valve. The device and method are also envisioned for use in treating valves in other parts of the circulatory system.

As described herein, a sutureless prosthetic valve comprises a valve grasper, such as the valve grasper 10 shown in FIGS. The valve grasper may alternatively be referred to as a sinus locator, valve positioner, or valve hanger. 1 and 2 illustrate a typical suture loop 60 threaded through a lumen 50 within a grasper leg member 30 to form a prosthetic valve with the grasper movably attached to a support frame. An embodiment is shown. Each of the valve graspers may be coupled to the prosthetic valve support frame by sutures, fabrics and/or flexible members, or other equivalent mechanisms or structures.

The sutureless prosthetic valve is delivered to the defective native valve using, for example, apical delivery, in which case the delivery device containing the prosthetic valve is delivered through an introducer with a hole in the chest wall. Introduced into the left ventricle of the heart. A typical transport device 100 is shown in FIG.

At the distal end of the delivery device 100 is a first sheath 110 (alternatively, a nose cone) that houses the support frame 170 in a compact state. The valve grasper 140 (expanded state shown in FIG. 5) is housed within the second sheath 120 and is movably coupled to the support frame 170 prior to delivery and placement of the prosthetic valve. As shown in FIG. 6, the U-shaped valve 150 of the valve grasper 140 is finally located between the natural leaflets 80 and the vessel wall 70. The delivery device 100 also includes at least one track wire 180 that is temporarily coupled at its distal end to the proximal end of the leg member 160 of the valve grasper 140. Each leg of the valve grasper is equipped with one track wire. Track wire 180 forms an operative connection between leg member 160 and control unit 260. The control unit 260 may be composed of multiple parts that operate independently of each other or in combination with each other. For example, the control unit 260 can include individual units including, but not limited to, a nose cone control unit, a sheath control unit, a release unit, and a handle. The handle may be part of a control unit that provides a place for the physician to hold the delivery device 100, but need not necessarily have other functions (see, eg, handle portion 266 of FIGS. 4 and 5). .. It should be understood that any of the transport devices described herein has a control unit for controlling various components of the transport device. Such control units will be understood by those skilled in the art. The control unit is composed of independent control elements, which may be arranged independently of one another or in coordination with one another in order to control the various components of the transport device in any way that enables their operation. The independent control unit may be, for example, a lever, a knob, or a first sheath, a second sheath, a prosthetic valve, each or all valve graspers, and other similar controls for controlling the movement of each or all track wires. Including structure. In one embodiment, one or more independent control elements appear as part of an independently rotatable control unit 260, such as 264, 266, and 268 shown in FIGS. 4-5. Each of these independent control elements can be ordered in any way. In one embodiment, the handle portion remains stationary with respect to the movement of the independent control element.

The second sheath 120 may bend to allow the second sheath 120 to maintain a bent configuration that matches the natural curvature of the heart and associated blood vessels near the location of the defective valve to be replaced. It can be made of any material that can. Imaging of the patient is performed in the area of the defective valve prior to performing the implantation procedure. Imaging can be performed, for example, by ultrasound, x-ray, and/or magnetic resonance imaging (MRI). Such imaging allows the physician to bend the second sheath 120 to an angle that is the angle of approximately curvature seen by imaging. Bending the second sheath 120 can prevent or reduce problematic contact between the delivery device 100 and the luminal surface of a blood vessel or the inner surface of a ventricle. Such contact may cause, for example, puncture of blood vessels or damage to heart tissue. A compatible bent configuration as contemplated herein allows for delivery of a prosthetic valve using device 100 during a delivery procedure without causing damage to blood vessels or heart tissue. Says the angle. Alternatively, compatible bend configurations occur when the second sheath 120 is rigid or when the second sheath 120 is unable to maintain a straight or bend configuration (such as a soft tube). The angle that reduces damage to any blood vessels or heart tissue during the delivery procedure, as compared to the damage that can occur.

The flexibility of the second sheath is achieved by manufacturing the second sheath with a metal support structure, where the metal maintains its bent shape in the absence of external forces after bending the metal. It is. Thus, the second sheath can be bent to a particular angle prior to or during the delivery of the delivery device into the patient, and after being bent, the second sheath can be passed through the delivery of the prosthetic valve and as needed. Accordingly, the bending angle (three-dimensional structure) is maintained during the recovery of the transport device. A non-limiting example of such a metal is stainless steel. The metal support structure may be a braid of metal wires, a wire mesh and/or a coil of metal wires. The wire may or may not be flat. The thickness of the wire can be varied, as can the density of the wire braid, mesh or coil, to vary. In other words, the flexibility of the sheath increases as the number of wires per unit area increases. In this embodiment, the second sheath 120 can be made of any material that allows the physician to manually bend the second sheath 120 without the assistance of others or tools. .. Alternatively, the physician can use the tool to bend the second sheath 120 into a compatible bent configuration. In one embodiment, the implantation device is constructed to include a sheathing cable that can be used to bend the second sheath before or during the delivery procedure. In one embodiment, the sheathing cable is positioned within and through the lumen of the second sheath. The sheathing cable may be attached at or near the distal end of the second sheath, in which case the bond is located at or near the distal end of the second sheath. The proximal end of the component cable may be free or may be attached to a component of the delivery device. In one embodiment, the proximal end of the configuration cable is attached to the control unit. In other embodiments, the proximal end of the configuration cable is attached to an independent configuration control lever. After the second sheath 120 has been bent into a bent configuration, during the delivery procedure, the bent configuration has an angle of ±1°C, ±2°C, ±3°C, ±4°, or ±5°. It is supposed to be able to maintain. Examples of these embodiments are shown in Figures 11-12.

An example of a reversible connection between the track wire 180 and the leg member 160 of the valve grasper 10 is shown in Figure 3C. Prior to delivery and placement of the prosthetic valve, the distal end of the track wire 180 is sewn into the leg member lumen 50 and bent back approximately 180 degrees. The track wire sheath 250 is pulled proximally until the track wire sheath 250 is pulled proximally so that the track wire 180 can be unrolled and unstitched through the leg member lumen 50. The wire sheath 250 accommodates the bent track wire 180 and maintains the bond between the track wire 180 and the leg member 160. Those of ordinary skill in the art will appreciate that many standard methods and devices reversibly open the trackwire in a manner that allows for controlled release from the trackwire valve grasper after placement and implantation of the prosthetic valve. It is understood that it can be used to connect to a prosthetic valve.

The transfer device 100 further includes a valve transfer body as shown in FIGS. 3A and 3B. As shown in FIGS. 3A, 3B and 4, the valve carrier 270 is located within the first sheath 110 prior to the delivery of the prosthetic valve. The valve carrier 270 comprises a proximal disc member 272 and a distal disc member 274 with a central stem 276 joining them. As shown in FIG. 3, the support frame 280 is located between the proximal disc member 272 and the distal disc member 274 when the support frame 280 is in a compact state within the first sheath 110. The valve carrier serves to hold the support frame compactly stationary within the first sheath during the delivery of the prosthetic valve to the defective annulus. When the first sheath moves distally with respect to the valve carrier, the support frame can expand radially within the annulus, at which time the valve carrier extends through the lumen of the deployed support frame. It can be arranged to move through and thereby be removed from the patient's body by the delivery device.

4-7 shows the control unit 260. The control unit 260 is designed to allow the user to individually control the operation of the delivery device and the operation of different parts of the prosthetic valve, as described for the delivery method below. Thus, the first sheath, the second sheath, the valve grasper, the track wire and the valve carrier are individually controlled, which means that each of these is proximal to the prosthetic valve and the rest of the delivery device independently. It also means that it can be moved distally. The design and use of control units, as described herein, that can individually control the parts involved in the transport is well known to those skilled in the art.
Method of transportation

The delivery device 100 can be advanced to the annulus in the direction of blood flow through the blood vessel or heart. A transportation method using the transportation device 100 will be described below with reference to FIGS.

In one embodiment, the trocar is inserted through the chest wall and the delivery device is advanced along the guidewire, through the defective valve, and past it. Prior to delivery and when the delivery device is advanced to the defective valve, the support frame 170 is in a compact state and fully contained within the first sheath 110. Also, as described above and as shown in FIGS. 3A and 3B, the valve carrier is contained within the first sheath 110. The valve grasper 140 is in a compact state and is sufficiently contained in the second sheath 120. As shown in FIGS. 1 and 2, the support frame 110 and the valve grasper 140 are, for example, movably attached by suture loops. Each leg member 160 of the valve grasper 140 is reversibly attached to the track wire 180 at its distal end, which in turn is attached to the control unit 260 at its proximal end. The delivery device 100 also includes a track wire sheath (not shown) that houses the track wire 180 as described above (see FIG. 3C).

When the first sheath 110 and the second sheath 120 are advanced with the guide catheter 265 along the guidewire to or over the defective annulus, the U-shaped member 150 also receives the defective valve. In the distal position with respect to the annulus, the second sheath 120 is moved proximally at least independently of the valve grasper 140, the first sheath 100 and the support frame 130. This exposes the U-shaped members 150, allowing them to expand radially as shown in FIG.

At this time, the first sheath 110 is moved in the proximal direction independently of the second sheath 120 until the support frame 170 is aligned with the proximal end of the U-shaped member 150. The delivery device 100 is then moved proximally until the U-shaped member 150 contacts the commissure between each defective leaflet 280 and the vessel wall 290 (see Figure 6). In an alternative method, the device 100 is pulled proximally until the U-shaped member 150 contacts the commissure between each defective leaflet 280 and the vessel wall 290, then the first sheath 110. Is independently moved proximally to the second sheath 120 until the proximal end of the support frame 170 is aligned with the proximal end of the U-shaped member 150.

When the U-shaped member 150 is aligned with the support frame 130 and the U-shaped member 150 is seated in the commissure between each defective leaflet 280 and the vessel wall 290 (see FIG. 6), the support To allow the frame 130 to expand sufficiently radially, the first sheath 110 is moved at least independently of the support frame 130, the valve carrier and the valve grasper 140. The disposed support frame 130 is shown in FIG. The valve carrier is not shown in this figure. Note that the track wire 180 is still coupled to the valve grasper 140 and the control unit 260.

As mentioned above, for example, the control unit 260 is operated to open the track wire 180. The delivery device 100 can now be moved proximally to remove the device from the patient. In one embodiment, prior to removal of the delivery device 100, the second sheath 120 is independently moved distally until it is substantially adjacent the first sheath 110.
III. Surgical delivery device for catheter-based delivery of prosthetic heart valves

This specification describes a sutureless prosthetic valve delivery device suitable for percutaneous delivery of a prosthetic valve for repairing a damaged heart valve. The device is particularly useful for repairing aortic, pulmonary, mitral or tricuspid valves. In this regard, the expandable support frame, to which the prosthetic leaflets are attached, is housed in a flexible tube for delivery, which allows the device to be relatively close to a defective heart valve. The blood vessels leading from the access points to the heart valves can be easily moved while minimizing or eliminating damage to the vessel walls.

It is envisioned that this device will be particularly useful for surgical procedures where the incision is performed in a blood vessel near the heart. These vessels, such as the aorta, carotid artery, subclavian artery, brachiocephalic artery, superior vena cava, pulmonary artery and vein are, for example, the femoral artery, which is the most utilized route for percutaneous delivery of artificial valves. It has a relatively large diameter, which is larger than the diameter. Thus, the device offers various improvements, for example, in the delivery and implantation of a sutureless prosthetic valve by reducing damage to the inner wall of the vessel through which the delivery device is advanced.

An implantable device with a delivery device for retrograde delivery of a prosthetic heart valve is described below. The implant device includes a delivery device and a prosthetic valve. The delivery device comprises an outer sheath for passing through the blood vessel or chamber wall. The sheath may be composed of polymeric or polymeric and metallic materials (eg, braided or coiled to provide additional strength, kink resistance, etc.). The delivery sheath can be retracted to open the valve grasper and valve frame of the prosthetic valve.

The configuration of the device during delivery of a defective valve and after placement of the support frame is shown in Figures 8-10. As described above, the delivery device 400 includes the first sheath 410, the second sheath 420, and the artificial valve, the first sheath 410 is located distal to the second sheath 420, and the second sheath 420 is the control unit. Located distally (not shown in FIGS. 8-10), a support frame with artificial leaflets is movably coupled to the valve grasper. The distal tip of the delivery device may be angled for a more aligned arrangement in the natural anatomy. The angle can be about 1 to 45 degrees, or 5 to 30 degrees.

FIG. 10 shows a suture loop 350. As mentioned above, there is a suture loop for each leg member of the valve grasper to provide a moveable attachment to the support frame. Prior to delivery, both the support frame 430 and the proximal portion of the valve grasper 440 (including the U-shaped member 450) are compact within the second sheath 420. The delivery device 400 further includes a locking member 480 disposed within the first sheath (nose cone). Each of the respective distal ends of the valve grasper leg members 460 are disposed within the first sheath 410 between the locking member 480 and the inner surface of the first sheath 410. The locking member 480 can be made from a shape memory material such as Nitinol, thus providing the radial force necessary to secure the proximal end of the grasper leg member 460 to the first sheath 410. Since the support frame 430 is optionally aligned with the valve grasper 440 prior to the placement of the support frame 430, the carrier device 400 further positions the support frame 430 within the second sheath 420 in a compact position. A stabilizing member 490 can be provided that can function as a reaction force to maintain

The second sheath 420 is a material that allows the second sheath 420 to have the appropriate flexibility and strength to deliver the prosthetic valve to the heart valve, while not damaging the vessel in which the delivery device travels. Constructed from materials that do not cause damage or minimize damage. In one embodiment, the second sheath 420 is braided or constructed in such a way as to provide sufficient flexibility, or otherwise manufactured using other methods known to those skilled in the art. It may include plastics, or polymers and metal wires, which are described in more detail above.
In another embodiment, the second sheath 420 is made as described in US Application Publication No. 2010/0274088. The content of this application is incorporated herein by reference in its entirety.

An example showing the flexibility of the second sheath is shown in FIGS. 11-12. 11 and 12 show the first sheath 51
0 illustrates an embodiment of an implant device 500 having a 0, a second sheath 520 and a control unit 530. FIG. 11 shows two configurations of the second sheath 520, shown as 520a in the first bent conformation and 520b in the second bent conformation. In one embodiment, the bend of the second sheath 520 includes a bending conformational element 540 attached to the proximal end of a sheathed cable attached to the second sheath 520.
Controlled through. This is the sheath structure cable 5 located in the lumen of the second sheath 520.
Further shown in FIG. 12 showing 50. The distal end of the sheathing cable 550 has a second
Attached to the inner surface of the second sheath 520 at or near the distal end of the sheath 520. The proximal end of the sheathing cable 550 may be free or attached to a moveable element of the control unit 530 that allows control of the sheathing cable 550. For example, the second sheath 520 is bent by pulling the bending three-dimensional structure 540 and/or the sheath structure cable 550. Another embodiment of an implant device is shown in FIG. FIG.
Shows an exemplary embodiment of an implant device 700 in which the prosthetic valve and valve grasper described above are fully or partially contained within a first sheath prior to insertion of the implant device into a patient. To be done.
As shown in FIG. 13, artificial valve 710 and valve grasper 720a, 720b, and 720c are
Fully contained within the first sheath 720. In this embodiment, the U of the valve grasper 720abc
The letter-shaped member is located distal to the prosthetic valve 710. The U-shaped member is fully or partially covered by the first sheath. In some embodiments, the prosthetic valve is fully contained by the first sheath. FIG. 13 illustrates one embodiment of a control unit, shown here as control unit 750. In this embodiment, the control unit 750 includes a spring control element (shown as spring control element 740), a sheath control element (shown as sheath control element 780), a release knob (shown as release knob 770), and a handle 760 ( (Shown as handle 760). The implant device also includes a second sheath that can be referred to as a nose cone. The diameter of the second sheath decreases towards the distal end of the second sheath as compared to the central portion of the second sheath (which provides the second sheath in the form of a nose cone). The diameter of the second sheath may also decrease towards the distal end of the second sheath as compared to the central portion of the second sheath, whereby the second valve is delivered before, during and after delivery of the prosthetic valve. The proximal end of the sheath can be contained or covered by the first sheath. This feature of the proximal end of the second sheath is in part advantageous because it is provided by the proximal end of the nose cone during delivery of the prosthetic valve and/or retrieval of the implant device from the patient. This is because it reduces or prevents damage caused to the blood vessel wall or surrounding tissues. A particular embodiment of the second sheath is shown in FIG. 13 as the second sheath 730. The second sheath may be solid (non-hollow) with a central lumen, or it may be hollow. The second sheath will have holes or openings at its proximal and distal ends. The second sheath shaft can be attached to the second sheath. The second sheath shaft may be made as part of the second sheath, or the distal end of the second sheath shaft may have a second end.
It can be attached to the central part of the sheath. An embodiment of the second sheath shaft is shown in FIG. 13 as the second sheath shaft 730.

As shown in FIG. 13 and described above, the implant device further includes one or more track wires.
The distal end of each of the one or more track wires is attached to each of the support frames. In one embodiment, the distal end of each of the one or more track wires is attached to the proximal end of the support frame. Multiple track wire embodiments are shown in FIG. 13 as 725a, 725b, and 725c.

In one embodiment, the implantable device further comprises a spring mechanism with a spring attached to the proximal end of the second sheath and the first sheath control element within the control unit. A first sheath control element is used to control distal and proximal movements of the first sheath, where the first sheath houses a prosthetic valve and a valve grasper fully or partially. Can be accommodated. Prior to implantation, the spring is in a partially or fully compressed state. If the distal end of the implant device is diverted towards the defective annulus and the distal end of the implant device is once near, within, or past the defective annulus: The first sheath control element is manipulated (eg, rotated and/or moved left, right, up and down) to move the first sheath in a direction that partially or fully exposes the grasper. When the first sheath control element is manipulated, the proximal end of the second sheath, which is coupled to the spring via the second sheath shaft, stays near the distal end of the first sheath, and the proximal The end remains within about 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 1 cm, 1.5 cm from the distal end of the first sheath. In some embodiments, the relatively narrow proximal end of the second sheath may be within the lumen of the distal end of the first sheath. The first sheath control element is manipulated until it hits the hard stop portion and the proximal end of the second sheath is no longer maintained near the distal end of the first sheath (the proximal end of the second sheath is No more than about 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 1 cm, 1.5 cm or more away from the distal end of one sheath). Only the spring and the second sheath hit the hard stop. When hitting this hard stop portion, the U-shaped member of the valve grasper is at least partially or fully exposed from the first sheath. The first sheath is still movable in both distal and proximal directions by manipulation of the first sheath control element.

Upon hitting the hard stop portion, the first sheath control element can be further manipulated to move the first sheath proximally. Therefore, at least the U-shaped member of the valve grasper is no longer covered by the first sheath, and after radial expansion until each valve grasper is properly placed in the defective annulus. , The implant device is moved toward the defective annulus as described above. Once the valve grasper is properly placed in the defective annulus, the first sheath is used to place the prosthetic valve support frame out of the cover and place the artificial valve in the natural annulus as described above. The control element is manipulated to move the first sheath proximally. In this case, the natural leaflets are compressed between the expanded support frame and the valve grasper.

A particular embodiment of this implant device with a spring mechanism is shown in FIG. The second sheath 730 is at the distal end of the implant device 700. In this embodiment, the second sheath 730 is shaped such that the diameter of the distal and proximal ends of the second sheath 730 is smaller than the intermediate diameter of the second sheath. Further, the proximal end of the second sheath 730 is at least partially contained by the first sheath 720. The first sheath 720 sufficiently accommodates the artificial valve 710 and the plurality of valve graspers 720a, b, c. Each valve grasper 720a,b,c is coupled to the support frame of the prosthetic valve 710 by sutures, fabric, or flexible members. The proximal end of each release cable 725a,b,c is directly or indirectly attached to a release control element 770 that is part of control unit 750. The control unit 750 can be configured in various ways, as will be appreciated by those skilled in the art, and FIG. 13 is not intended to be limited to a particular configuration. The control unit 750 provides an example of a control unit of an implantable device having control elements for independently or cooperatively operating portions of a prosthetic valve delivery device, the delivery device comprising a first and second sheath, a prosthetic valve. , But not limited to, if present, track wires and springs. FIG. 13 also shows an embodiment in which the control unit 750 includes a second sheath automatic control element 745. The automatic control element 745 accommodates at least a portion of the spring 740, the spring being attached to the second sheath shaft 730 at its distal end and to the automatic control element 745 at its proximal end. The control element 780 of the first sheath shown in FIG. 13 can be manipulated to control the proximal and distal movement of the first sheath 720, resulting in partial extension of the spring 740, as described above. , Which in turn allows the second sheath 730 to remain near the distal end of the first sheath 720, as described above. In the embodiment shown in FIG. 13, rotation of the first sheath control element 780 results in a hard stop in which the spring 740 no longer extends and the first sheath 720 is proximally exposed to expose the prosthetic valve 710. Further rotation of the first sheath control element 780 to move it in the direction would cause the first sheath 720 to move independently of the second sheath 730. Once the prosthetic valve 710 is fully exposed and deployed, the release knob 770 can be manipulated to release the track wires 790a,b,c from the valve graspers 720a,b,c, and the first sheath. The control element 780 can be rotated in the opposite direction to bring the proximal end of the second sheath 730 into close proximity with the distal end of the first sheath 720. The implant device 700 can then be removed from the patient with no or little damage to the patient's vessel wall or tissue.
Method for transportation

The delivery device 400 is designed to allow retrograde delivery of the prosthetic valve, i.e., in the opposite direction of blood flow through the defective valve. A method for delivery using the delivery device 400 and an implantable device with the movably mounted prosthetic valve described above will be described with reference to FIGS. 8-10. The distal end of the delivery device is partially guided using a guide catheter 390 until the first sheath 410 is within the generally defective annulus and the second sheath 420 is proximate to the natural leaflets 370. Is advanced along. The second sheath 420 is then moved proximally, while the valve grasper 440 remains stationary along the longitudinal axis. The U-shaped member 450 of the valve grasper 440 is exposed and the U-shaped member 450 expands radially.

At this time, the second sheath 420 moves distally, while the valve grasper 440 remains stationary along the longitudinal axis. This movement of the second sheath 420 functions to align the support frame 430 with the valve grasper 440, thereby properly aligning the support frame 440 and its associated prosthetic valve within the annulus. Importantly, the support frame 430 moves relative to the valve grasper 440 along its longitudinal axis to become concentric with the valve grasper 440. This carrying is possible in part by the sides movably coupled to the prosthetic valve, and in this particular example, is then provided by the suture loop 350. As the support frame 430 moves distally, the suture loop 350 slides along the leg members of the valve grasper 440 as described above. The delivery device 400 then moves distally until the U-shaped member 450 contacts the commissure between each defective leaflet 370 and the vessel wall 360.

Alternatively, after the U-shaped member 450 is exposed and radially expanded, the device 400 may be contacted until the U-shaped member 450 contacts the commissure between each defective leaflet 370 and the vessel wall 360. Is advanced distally, at which time the first sheath 420 aligns the distal end of the support frame 430 with the U-shaped member 450 so that the support frame 430 properly aligns with the native valve annulus. Until it is moved distally independently of the first sheath 410.

The second sheath 420 is advanced distally, in which case holding the valve grasper 440 stationary will release the locking member 480 from the first sheath. As a result, the leg members of the valve grasper 440 are no longer locked within the first sheath 410, thereby allowing subsequent radial expansion of the support frame 430.

Once the U-shaped member 450 is properly aligned with the support frame 430 and the U-shaped member is seated in the commissure between each defective leaflet 370 and the vessel wall 360 (see FIG. 9), The 1-sheath 420 moves proximally along the longitudinal axis, at least independently of the support frame 430 and the valve grasper 440, to allow for sufficient radial expansion of the support frame 430. Arranged, the support frame 430 is shown in FIG. Once the support frame 430 is fully deployed, the native leaflet 370 is sandwiched between the U-shaped member 450 and the support frame 430, thereby placing the prosthetic valve in its proper and functional position within the native heart valve annulus. Fix it. At this point, the transport device 400 is removed from the patient.

The implant device described herein comprises a control unit (not shown in Figures 8-10). The control unit is designed and manufactured according to methods generally available to those of ordinary skill in the art and is operable to independently control at least the first sheath, the second sheath, the valve grasper, the support frame, the locking member, and the stabilizing member. To do.

Although a number of exemplary aspects and embodiments have been described above, those of skill in the art will recognize modifications, substitutions, additions and subcombinations thereof. Accordingly, the subject matter of the appended claims and the claims introduced hereinafter includes all such changes, substitutions, additions and subcombinations as are within their true spirit and scope. Is intended to be interpreted as

Claims (9)

An artificial valve carrier,
A first sheath containing a valve grasper;
A second sheath containing an expandable support frame; and a control unit,
The valve grasper and the support frame are movably mounted; and along the longitudinal axis the first sheath is distal of the second sheath and the second sheath is distal of the control unit. ,
The artificial valve carrier. The artificial valve carrier according to claim 1, further comprising a valve carrier housed in the first sheath. The artificial valve delivery device according to claim 1 or 2, wherein the artificial valve is used for treating a defective aortic valve. A method of placing an artificial heart valve at a transplant site in a patient, said method comprising:
Introducing the distal end of the valve delivery device, said delivery device comprising:
A first sheath containing an expandable support frame with a valve structure attached; a second sheath containing a valve grasper with three U-shaped members and three leg members, said support frame and valve grasp The vessel is movably mounted, and the first sheath is along the longitudinal axis and distal of the second sheath; and comprises three track wires, each of the three track wires having three leg members. Transporting device reversibly attached to each of the
Advancing the distal end of the delivery device in the direction of blood flow to the defective heart valve until the three U-shaped members are located distal to the defective heart valve annulus;
Pulling the second sheath proximally to expose the three U-shaped members; to align the proximal end of the support frame with the proximal ends of the three U-shaped members , Pulling the first sheath proximally;
Advancing the first sheath independently of the support frame to expose the support frame;
Removing each of the three track wires from the three leg members; and removing the delivery device from the patient,
The method comprising: 5. The method of claim 4, wherein the first sheath houses a valve grasper that holds the support frame stationary within the first sheath before the support frame is deployed. An artificial valve carrier,
A first sheath containing at least one U-shaped member of the valve grasper and an expandable support frame;
A second sheath containing the locking member and the distal portion of the leg member of the valve grasper;
And a control unit,
The valve grasper and support frame are movably mounted, and along a longitudinal axis the first sheath is distal of the second sheath and the second sheath is distal of the control unit. is there,
The artificial valve carrier. 7. The delivery device of claim 6, further comprising a stabilizing member housed in the second sheath at a proximal position of the support frame. A method of placing an artificial valve at a transplant site of a patient, said method comprising:
Introduce the distal end of the valve delivery device into a patient's blood vessel,
The valve carrier is
A first sheath containing at least one U-shaped member of the expandable support frame and the valve grasper; and
A second sheath accommodating the locking member and the distal portion of the valve grasper leg member;
The valve grasper and the support frame are movably mounted, a valve carrier.
Advancing the valve delivery device through the blood vessel toward the defective natural annulus until the first sheath is substantially within the defective natural annulus;
Pulling the second sheath proximally while holding the valve grasper stationary along the longitudinal axis until at least one U-shaped member expands radially;
Moving the second sheath distally while holding the valve grasper stationary along the longitudinal axis until a support frame is aligned with the valve grasper;
Move the placement device proximally until the at least one U-shaped member contacts the natural sinus; and move the support frame and valve grasper longitudinally until the support frame is placed. Moving the second sheath in a proximal direction while remaining stationary along the second sheath. 9. The method of claim 8, wherein the blood vessel is the aorta, the superior vena cava, or the pulmonary vein or artery.

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